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Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.
Vaccine. 2019 03 22; 37(13):1836-1843.V

Abstract

BACKGROUND

A phase III, randomized, double-blind, placebo-controlled clinical study was conducted in China to assess the efficacy, safety, and immunogenicity of the pentavalent rotavirus vaccine (RotaTeqTM, RV5) among Chinese infants. The efficacy and safety data have been previously reported. This report presents the immunogenicity data of the study.

METHODS

4,040 infants aged 6-12 weeks were randomly assigned in a 1:1 ratio to receive 3 oral doses of RV5 or placebo. Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) were administered in a staggered-use (N = 3,240) or concomitant-use (N = 800) schedule. Immunogenicity of RV5 was evaluated in 800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup). Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3) were measured for anti-rotavirus IgA in the staggered- and concomitant-use subgroups and measured for serum neutralizing antibodies (SNAs) to human rotavirus serotypes G1, G2, G3, G4, P1A[8] in the staggered-use subgroup. Immune responses to tOPV and DTaP co-administered with RV5 were also evaluated in the concomitant-use immunogenicity subgroup. (ClinicalTrials.gov registry: NCT02062385) RESULTS: The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%). Rotavirus type-specific SNA responses were also higher in the RV5 group compared to the placebo group. In the concomitant-use subgroup, the seroprotection rates of anti-poliovirus type 1, 2, 3 in the participants who received RV5 were non-inferior to those who received placebo, and the antibody responses to DTaP antigens were comparable between the two vaccination groups.

CONCLUSIONS

RV5 was immunogenic in Chinese infants. Immune responses induced by tOPV and DTaP were not affected by the concomitant use of RV5.

Authors+Show Affiliations

Guangxi Center for Disease Control and Prevention, Guangxi, PR China.National Institutes for Food and Drug Control, Beijing, PR China.National Institutes for Food and Drug Control, Beijing, PR China.Guangxi Center for Disease Control and Prevention, Guangxi, PR China.Merck & Co., Inc., Kenilworth, NJ, USA.MSD R&D (China) Co., Ltd., Beijing, PR China.MSD R&D (China) Co., Ltd., Beijing, PR China.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.No affiliation info availableMSD R&D (China) Co., Ltd., Beijing, PR China. Electronic address: xue.yan.liao@merck.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30808567

Citation

Mo, Zhaojun, et al. "Immunogenicity of Pentavalent Rotavirus Vaccine in Chinese Infants." Vaccine, vol. 37, no. 13, 2019, pp. 1836-1843.
Mo Z, Ma X, Luo P, et al. Immunogenicity of pentavalent rotavirus vaccine in Chinese infants. Vaccine. 2019;37(13):1836-1843.
Mo, Z., Ma, X., Luo, P., Mo, Y., Kaplan, S. S., Shou, Q., Zheng, M., Hille, D. A., Arnold, B. A., & Liao, X. (2019). Immunogenicity of pentavalent rotavirus vaccine in Chinese infants. Vaccine, 37(13), 1836-1843. https://doi.org/10.1016/j.vaccine.2019.02.018
Mo Z, et al. Immunogenicity of Pentavalent Rotavirus Vaccine in Chinese Infants. Vaccine. 2019 03 22;37(13):1836-1843. PubMed PMID: 30808567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of pentavalent rotavirus vaccine in Chinese infants. AU - Mo,Zhaojun, AU - Ma,Xiao, AU - Luo,Peng, AU - Mo,Yi, AU - Kaplan,Susan S, AU - Shou,Qiong, AU - Zheng,Minghuan, AU - Hille,Darcy A, AU - Arnold,Beth A, AU - ,, AU - Liao,Xueyan, Y1 - 2019/02/23/ PY - 2018/06/15/received PY - 2018/12/27/revised PY - 2019/02/03/accepted PY - 2019/2/28/pubmed PY - 2020/8/13/medline PY - 2019/2/28/entrez KW - China KW - Immunogenicity KW - Pentavalent rotavirus vaccine SP - 1836 EP - 1843 JF - Vaccine JO - Vaccine VL - 37 IS - 13 N2 - BACKGROUND: A phase III, randomized, double-blind, placebo-controlled clinical study was conducted in China to assess the efficacy, safety, and immunogenicity of the pentavalent rotavirus vaccine (RotaTeqTM, RV5) among Chinese infants. The efficacy and safety data have been previously reported. This report presents the immunogenicity data of the study. METHODS: 4,040 infants aged 6-12 weeks were randomly assigned in a 1:1 ratio to receive 3 oral doses of RV5 or placebo. Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) were administered in a staggered-use (N = 3,240) or concomitant-use (N = 800) schedule. Immunogenicity of RV5 was evaluated in 800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup). Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3) were measured for anti-rotavirus IgA in the staggered- and concomitant-use subgroups and measured for serum neutralizing antibodies (SNAs) to human rotavirus serotypes G1, G2, G3, G4, P1A[8] in the staggered-use subgroup. Immune responses to tOPV and DTaP co-administered with RV5 were also evaluated in the concomitant-use immunogenicity subgroup. (ClinicalTrials.gov registry: NCT02062385) RESULTS: The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%). Rotavirus type-specific SNA responses were also higher in the RV5 group compared to the placebo group. In the concomitant-use subgroup, the seroprotection rates of anti-poliovirus type 1, 2, 3 in the participants who received RV5 were non-inferior to those who received placebo, and the antibody responses to DTaP antigens were comparable between the two vaccination groups. CONCLUSIONS: RV5 was immunogenic in Chinese infants. Immune responses induced by tOPV and DTaP were not affected by the concomitant use of RV5. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/30808567/Immunogenicity_of_pentavalent_rotavirus_vaccine_in_Chinese_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(19)30213-0 DB - PRIME DP - Unbound Medicine ER -